April30, 2019

House companion legislation to Klobuchar’s Preserve Access to Affordable Generics and Biosimilars Act and the Stop STALLING Act, and the Klobuchar-backed CREATES Act passed the House Judiciary Committee today

WASHINGTON – U.S. Senator Amy Klobuchar (D-MN), Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, released the following statement today after the House Judiciary Committee passed major legislation to help lower the price of prescription drugs, including two bills she leads in the Senate. The Preserve Access to Affordable Generics and Biosimilars Act would limit anticompetitive pay-for-delay deals that prevent or delay the introduction of affordable follow-on versions of branded pharmaceuticals. The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING)Act would curb the abuse of the U.S. Food and Drug Administration (FDA) petition process and increase access to affordable prescription drugs. TheKlobuchar-backed Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to delay the approval of lower-cost generic drugs.

“The skyrocketing cost of prescription drugs in our country is an urgent problem, but there are solutions on the table to help Americans access the critical medications they need at prices they can afford,” Klobuchar said. “With the passage of my bills out of the House Judiciary Committee today, we are one step closer to ending the unfair practices that drive up prescription drug costs.”

The Preserve Access to Affordable Generics and Biosimilars Act, led in the Senate by Klobuchar and Senator Chuck Grassley (R-IA), would enhance the Federal Trade Commission’s ability to crack down on anticompetitive patent settlement agreements in which branded pharmaceutical companies pay their competitors to delay the introduction of more affordable generic drugs and biosimilars. Deterring “pay-for-delay” deals would make some critical prescriptions more affordable for patients and reduce costs on our healthcare system.

The Stop STALLINGAct, led in the Senate by Klobuchar and Grassley, would reduce the incentives for branded pharmaceutical companies to use the FDA petitioning process to interfere with the regulatory approval of generics and biosimilars that would compete with their own products, a tactic that delays patient access to more affordable medications. The bill would give the Federal Trade Commission (FTC) enhanced authority to take action against those who file sham petitions.

The CREATES Act, led in the Senate by Senator Patrick Leahy (D-VT) and Grassley with Klobuchar, Senator Mike Lee (R-UT), and others would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to delay the approval of lower-cost generic drugs. The bill would address two types of delaying tactics: (1) when brand-name drug companies prevent potential generic competitors from obtaining samples of a product; and (2) when brand-name drug companies block their generic competitors from participating in shared safety programs to ensure drugs are used safely. Both of these tactics prevent generic companies from performing the necessary testing and distribution necessary for FDA approval. By combatting these anticompetitive practices, the CREATES Act would help consumers access lower-cost generic drugs more quickly.

Klobuchar has long supported efforts to combat anti-competitive tactics in the pharmaceutical market and lower prescription drug costs by promoting competition in the healthcare system. Klobuchar introduced legislation—that has 34 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 43 million seniors enrolled in Medicare Part D. In January, Klobuchar and Grassley introduced the Safe and Affordable Drugs from Canada Act, bipartisan legislation that would allow individuals to safely import prescription drugs from Canada. Klobuchar’s Short on Competition Act, introduced with Lee, Grassley, and Senator Dick Durbin (D-IL) would allow the temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the United States.

In November 2018, Klobuchar and Grassley sent a letter to the President urging him to support legislation to limit anticompetitive “pay-for-delay” pharmaceutical settlements as part of the Administration’s effort to bring down the skyrocketing price of prescription drugs. Full text of the letter can be found here. In a June 2018 letter, Klobuchar and Grassley urged the FTC to examine whether makers of biologic medicines are using strategies like “pay-for-delay” to hinder or delay biosimilars from entering the market. Full text of the letter can be found here.